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3,068 stories matching this filter · ← front page

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  • Rapport Therapeutics' epilepsy drug RAP-219 meets primary endpoint in bipolar mania Phase II trial
    Rapport Therapeutics reported that its experimental pill RAP-219, originally developed for epilepsy, was tested in a mid‑stage study of adults with bipolar mania. The trial enrolled roughly 250 par…
    BioPharma Dive · 1h agoPositive readoutPositive↗ source
  • ICER reports two-thirds of new drugs launched 2022-2025 priced well above cost-effectiveness thresholds
    ICER’s latest analysis of launch prices for new prescription medicines shows a sharp rise in net costs between 2022 and 2025. After adjusting for inflation, the median price climbed from $190,000 i…
    BioPharma Dive · 2h agoNegative↗ source
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  • New drug launch prices climb 35% to $257,000 median, with a quarter exceeding $500,000
    A recent analysis of 202 newly launched medicines shows the median net price jumped 35% last year, reaching $257,000 compared with $173,000 in 2022. The study adjusted prices for inflation and typi…
    STAT · 7h agoRegulatoryNegative↗ source
  • Roche signs major partnership with China's Hansoh to co-develop antibody-drug conjugates
    Roche announced a deal with China's Hansoh Pharmaceutical Group to develop a portfolio of antibody-drug conjugates (ADCs). The agreement is described as massive, indicating a significant collabora…
    STAT · 1h agoDealPositive↗ source
  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 2h agoApprovalPositive↗ source
  • Median net price of new drugs jumps 35% from 2022 to 2025, reaching $257,000
    The Institute for analysis reports that the median net price for 202 newly launched medicines rose 35% between 2022 and 2025 after adjusting for inflation and manufacturer discounts. The median pr…
    STAT · 4h agoNeutral↗ source
  • FDA releases final guidance on prescription-drug companion apps and software
    FDA issued final guidance that creates a clear framework for how drug makers can develop, distribute and label mobile applications that accompany prescription medicines. The document answers three…
    fda press · 5h agoRegulatoryNeutral↗ source
  • Dana-Farber and Beth Israel Lahey Health break ground on $1.68 billion cancer hospital in Boston
    Officials from Dana-Farber Cancer Institute and Beth Israel Lahey Health announced the start of construction on a new dedicated cancer hospital in Boston's Longwood area. The project is budgeted at…
    STAT · 5h agoDealPositive↗ source
  • Pharma pours billions into bispecifics, ADCs and cell therapies despite limited clinical proof
    The article notes that emerging drug formats such as bispecific antibodies, antibody‑drug conjugates and cell therapies have yet to demonstrate clear clinical success, yet pharmaceutical firms cont…
    BioPharma Dive · 6h agoNeutral↗ source
  • Rapport Therapeutics' Phase 2 Bipolar Mania Trial Meets Primary Endpoint, Though Effect Size Below Target
    Rapport Therapeutics reported that its phase 2 study of RAP-219 in bipolar mania met the primary endpoint, showing a statistically significant improvement on the Young Mania Rating Scale (YMRS) at…
    Fierce Biotech · 8h agoPositive readoutNeutral↗ source
  • Midterm ballot measures spotlight abortion, transgender rights and Medicaid expansion
    Voters in the upcoming midterm elections will weigh a series of state ballot questions that address contentious health topics such as abortion access, transgender health care and the expansion of M…
    STAT · 9h agoRegulatoryNeutral↗ source
  • EY report says MedTech growth driven by commercial leaders, AI and expanding into new care settings
    The latest EY Pulse of the MedTech Industry report looks at the period from 2025 through the first half of 2026. It finds that innovation has spurred more dealmaking and R&D spending, while artific…
    Fierce Biotech · 13h agoPositive↗ source
  • Pfizer halts phase 2 trial of CXCR5 antibody for immune thrombocytopenia
    Pfizer announced it is ending a phase 2 study of its CXCR5-targeting antibody PF-06835375 in patients with primary immune thrombocytopenia (ITP). The decision was described as a business decision a…
    Fierce Biotech · 14h agoCRLNegative↗ source
  • Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw
    Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient. The FDA…
    fda medwatch · 14h agoCRLNegative↗ source
  • AstraZeneca partners with Oracle to boost clinical trial patient recruitment using AI
    AstraZeneca announced a collaboration with data-technology firm Oracle to apply artificial-intelligence tools to clinical-trial recruitment. The non-binding agreement will let the partners explore…
    Fierce Biotech · 15h agoDealPositive↗ source
  • Lawmakers push FDA to close loophole allowing import of counterfeit Eli Lilly obesity drug
    A bipartisan group of U.S. lawmakers is urging the Food and Drug Administration to address a regulatory gap that permits the importation of unapproved versions of retatrutide, an experimental obesi…
    STAT · 1h agoRegulatoryNeutral↗ source
  • Lycia Therapeutics targets $228M IPO to fund food allergy protein degrader programs
    Lycia Therapeutics announced plans for an initial public offering expected to raise about $228 million. The proceeds are intended to support its pipeline of protein degrader therapeutics targeting…
    Fierce Biotech · 10h agoDealNeutral↗ source
  • Proposed ACGME rule changes could strip resident doctors of mandatory rest periods
    Arifeen Rahman, a clinical instructor in rhinology at the Medical University of South Carolina, recounts working 90-hour weeks as a junior otolaryngology resident in 2023, often exceeding the ACGME…
    STAT · 9h agoRegulatoryNegative↗ source
  • New poll gauges U.S. voter attitudes toward transgender sports participation and abortion access
    A recent assessment released by STAT examines how American voters feel about transgender youth competing in school sports and about access to abortion services. The analysis is presented as a concr…
    STAT · 5h agoNeutral↗ source
  • JAMA paper on OpenEvidence highlights clinician use but raises unanswered questions
    A new study published in JAMA examines how clinicians are employing the OpenEvidence platform, an artificial-intelligence-driven tool designed to assist medical decision-making. The authors highli…
    STAT · 3h agoNeutral↗ source
  • Reporter urges audiences to skip new Elizabeth Holmes documentary
    Matthew Herper, a reporter covering medical innovation, recounts his two interviews with Elizabeth Holmes in 2015, at the peak of Theranos hype. The first interview occurred just before John Carre…
    STAT · 2h agoNegative↗ source
  • Early Alert: Cardinal Health Issues Correction for Presource Packs Containing BD Alaris Pump Infusion Sets
    Cardinal Health Presource Kits containing recalled BD Alaris Pump Infusion Sets should be corrected prior to continued use.
    fda medwatch · 14h ago↗ source
  • Early Alert: Cardinal Health Updates Use Instructions for Presource Packs Containing BD Alaris Pump Infusion Sets
    Cardinal Health Presource Kits may contain BD Alaris Pump Infusion Sets with Updated Use Instructions.
    fda medwatch · 14h ago↗ source
  • Roche signs up to $15 billion ADC partnership with China's Hansoh, paying $400 million upfront
    Roche announced a new partnership with Chinese drugmaker Hansoh Pharmaceutical Group focused on antibody‑drug conjugates. The agreement includes an upfront payment of $400 million and the potential…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Disc spins past FDA rejection with ‘overwhelmingly positive’ phase 3 data for rare disease drug
    A phase 3 trial of Disc Medicine’s bitopertin has hit both co-primary endpoints and all secondary endpoints, positioning the biotech to refile for approval of the once-rejected rare disease drug ca…
    Fierce Biotech · 1d agoApprovalPositive↗ source